MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins).Information was reported that the patient had a loss of stimulation in the correct areas and pain has returned.The patient also stated he feels like the stimulation is still on when the device stated it is off.An impedance check showed one electrode was out.The patient is not currently using stimulation.The issue was not resolved at the time of this report, but the patient is scheduled to have a revision on (b)(6) 2018.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Concomitant medical products: product id: 3776-60, serial (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead.Product id: 3487a-56, lot# v196547, implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep) on 2018-03-23.It was reported that the cause of the loss of stimulation was not determined.As an action/ intervention towards the issue all programs were turned off and health care professional (hcp) scheduled a lead revision.The information was confirmed by the health care professional (hcp).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the replacement unfortunately did not resolve the stimulation and pain issues even when all programs were removed.The patient is seeing the doctor today ((b)(6) 2018).The doctor is aware if the patient's issues.No further information was reported.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 37082-40, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: extension.Product id: 3776-60, serial# (b)(4), implanted:(b)(6) 2009, explanted: (b)(6) 2018, product type: lead.Product id: 3487a-56, lot# v196547, implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead.Evaluation summaries are listed below next to the serial # of each respective device.(b)(4): analysis of the ins found no evidence of anomalies.(b)(4): analysis identified that the outer insulation was melted; which is consistent with electrocautery use in the proximity of the extension.No significant anomaly found.(b)(4): analysis identified environmentally assisted degradation of the insulation at the proximal end of the lead.(b)(4): all conductors (ins circuits 12-15) are broken between 14.4 cm and 15.5 cm from the distal end.There are titan anchor impressions at 16.3 to 17.2 cm from the distal end.(b)(4): analysis identified that there was a break in the insulation under the {x} connector at the proximal end of the lead; consistent with explant damage.No significant anomaly found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7361486
• MDR Text Key: 103165112
• Report Number: 3004209178-2018-05519
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/23/2018; 04/12/2018; 06/18/2018
• Supplement Dates FDA Received: 04/11/2018; 05/04/2018; 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR